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Study on the Effectiveness of Gemcitabine Hydrochloride for Patients with Low Grade Bladder Cancer

Verified siteRegistered drugNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying bladder cancer, specifically a type known as low-grade bladder cancer. The treatment being tested is called GEMSOL, which contains the active substance gemcitabine hydrochloride. This medication is given directly into the bladder in a form known as a concentrate for solution for infusion. The purpose of the study is to evaluate how effective this treatment is for patients with this type of bladder cancer.

Participants in the study will receive the treatment over a period of time, and the study will monitor the response to the treatment. The main goal is to see if the treatment can completely remove visible tumors from the bladder. The study will also look at other outcomes, such as the overall response to the treatment, any side effects that occur, and how the treatment affects the quality of life of the participants.

This study is designed to provide important information about the potential benefits and risks of using GEMSOL for treating low-grade bladder cancer. The results will help determine if this treatment could be a useful option for patients with this condition in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Enrollment
Upon joining the study, eligibility is confirmed through a series of tests. This includes a diagnosis of a recurrent tumor or primary TaLG bladder cancer, confirmed by a biopsy within 8 weeks before screening.
Female patients of childbearing potential must have a negative pregnancy test within 2 weeks prior to enrollment and use adequate contraception during the study period.
A cystoscopy is performed to document the number, site, size, and appearance of tumors, with photo documentation. The largest lesion must be 15mm or smaller, and the number of lesions must be five or fewer.
Patients must have a negative voiding cytology for high-grade disease within 8 weeks before screening and no lymph node or distant metastasis.
Step 2
Treatment initiation
The treatment involves the use of GEMSOL, which contains gemcitabine hydrochloride. This medication is administered intravesically, meaning it is delivered directly into the bladder.
The pharmaceutical form is a concentrate for solution for infusion.
Step 3
Treatment schedule
The treatment consists of six instillations of GEMSOL over a period of 8 weeks. The exact schedule and dosage are determined by the study protocol.
Step 4
Monitoring and evaluation
Throughout the study, the response to treatment is monitored. The primary goal is to achieve a clinical complete response, which means the absence of visible tumors after treatment.
Secondary evaluations include pathological complete response, overall response, and monitoring for any treatment-related adverse events.
The rate of treatment discontinuation is also tracked, with a target of completing at least five out of six instillations within the 8-week period.
Health-related quality of life is assessed to understand the impact of the treatment on daily living.
Step 5
Study completion
The study is estimated to conclude by April 1, 2026. Participants are required to use effective contraception during the study and for a minimum of 6 months after the study treatment.

Who can join the trial?

11 criteria

Must have a diagnosis of a recurrent tumor and a history of TaLG BCa, or a diagnosis of primary TaLG BCa confirmed by a biopsy within 8 weeks before screening. TaLG BCa refers to a type of bladder cancer that is low-grade and non-muscle invasive.
Female patients who can have children must have a negative pregnancy test within 2 weeks before joining the study and must use effective birth control during the study.
Must be willing and able to provide informed consent, which means agreeing to participate after understanding the study details.
During the screening procedure called cystoscopy, the largest tumor must be 15mm or smaller in diameter.
Must have 5 or fewer tumors.
Must have a cystoscopy with a bladder diagram that includes the number, location, size, and appearance of the tumors, along with photo documentation.
Must have a recurrence of TaLG NMIBC, which is a type of bladder cancer that is low or intermediate risk according to EAU guidelines.
Must require treatment with a procedure called transurethral resection of bladder tumors (TURBT).
Must have a negative test result for high-grade disease within 8 weeks before screening. This test is called voiding cytology and checks for cancer cells in urine.
Must not have cancer spread to lymph nodes or other parts of the body.
Both male and female patients must use an effective contraceptive method during the study and for at least 6 months after the study treatment.

Who cannot join the trial?

5 criteria

Patients who do not have **bladder cancer** cannot participate.
Patients who are not within the specified age range cannot participate. The age range is typically defined by the study.
Patients who are not part of the specified clinical trial group cannot participate. This group is determined by the study.
Both **male** and **female** patients are eligible, so gender is not an exclusion criterion.
Patients who are considered part of a **vulnerable population** cannot participate. A vulnerable population includes groups like children, pregnant women, or those unable to give consent.

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Verified sites

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Medical University Of Vienna
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Vienna, Austria

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Investigated drugs

Gemcitabine is a medication used in this clinical trial to treat low-grade bladder cancer. It is administered directly into the bladder, a method known as intravesical therapy. The goal of using gemcitabine in this trial is to evaluate its effectiveness in treating patients with a specific type of bladder cancer called TaLG (Ta low-grade) bladder cancer. This approach aims to destroy cancer cells while minimizing exposure to the rest of the body.

Gemcitabine Hydrochloride

What is already known about the treatment

Gemcitabine – Gemcitabine is administered intravesically, meaning it is delivered directly into the bladder. It is currently being studied in clinical trials for its effectiveness in treating low-grade bladder cancer. The main therapeutic indication for gemcitabine in this context is bladder cancer, specifically for patients with TaLG (low-grade) tumors. At the molecular level, gemcitabine works by interfering with DNA synthesis, which prevents cancer cells from multiplying. It is classified as an antimetabolite, a type of chemotherapy drug that targets rapidly dividing cells.

Investigated diseases

Bladder Cancer – Bladder cancer is a disease where abnormal cells grow uncontrollably in the bladder, which is the organ that stores urine. It often begins in the cells lining the inside of the bladder and can spread to other parts of the body if not managed. The disease can cause symptoms such as blood in the urine, frequent urination, and pain during urination. Bladder cancer is categorized into different stages, with early stages being more localized and advanced stages involving deeper layers of the bladder or other organs. The progression of the disease can vary, with some cases remaining superficial and others becoming invasive. Regular monitoring and medical evaluation are important to understand the progression of bladder cancer.